HANDHELD

ANALYZER
FOR MATERIAL
VERIFICATION
AND
IDENTIFICATION
ASSURx® G7 RAMAN ANALYZER
HANDHELD ANALYZER FOR
MATERIAL VERIFICATION
AND IDENTIFICATION
The ASSURx instrument is a handheld Raman analyzer designed ASSURx HANDHELD RAMAN ANALYZER
for material verification and identification in the warehouse,
KEY FEATURES
loading dock, lab or plant floor – wherever the material is located.
++Ergonomic, Gun-style, point and shoot operation
The ASSURx analyzer verifies a material identity in 5-20 seconds,
++Efficient workflows for both individual material scans, and high
generates reports to satisfy regulatory compliance, and allows
volume operations with large lots of materials
materials to flow quickly through the manufacturing process.
++Individual and Lot Reports, with E-signatures
Decrease your sampling and laboratory costs, and increase your
inventory turns by incorporating an ASSURx Handheld Raman
The gun-shaped ASSURx analyzer is both ergonomically-designed,
Analyzer into your pharmaceutical, nutraceutical, or cosmetic
and intuitive to operate. There are just 3 simple steps to conduct a
manufacturing process today.
material verification once logged in:
1) Use the barcode scanner to scan in the material to be analyzed.
RAMAN TECHNOLOGY ADVANTAGES VS. NIR 2) Point the instrument so that it is in contact against a material’s
++Raman has broader material coverage than NIR
packaging.
++Raman can analyze liquids and aqueous samples directly through
3) Pull the trigger to initiate the analysis and see the Pass/Fail result
packaging, whereas handheld NIR struggles
on the screen.
++Raman is insensitive to particle size variations that can be found
in powdered raw materials. In contrast, NIR has difficulty with
For high-volume operations, the ASSURx analyzer auto-increments
different particle size distributions and requires averaging multiple
sample numbers, and generates Lot Reports so that batches of mea-
measurements
surements can be easily conducted and summarized. With E-signing
++Raman is insensitive to moisture variations. NIR is absorbed strongly
reports – it is easy for, supervisors to approve operator analyses.
by water, and can cause poor verification performance

ASSURx RAMAN ANALYZER ADVANTAGES
++Fast measurements, fast library development, and high selectivity
due to cooled, high-resolution spectrometer (5-20 second
measurement times are typical)
++Broad material coverage due to proprietary, advance fluorescence-
rejection algorithms, that allows for successful analysis of colored,
and darker materials
++Detection of samples with low Raman activity, like Bovine Gelatin,
with actively cooled detector
++Affordable analyzer with full compliance and support
++Fast material verifications: 5-20 seconds typical
++Fast library development, and easy library transferability
between units
++ Broad material coverage, for organics, powders and liquids
++ Proprietary data processing: advanced fluorescence-rejection
The ASSURx analyzer’s material verification mode is fast due to
its cooled detector and its proprietary data processing. The same
cooled detector and data processing engine also makes library entry
and creation fast. With an industry leading 6 cm-1, high resolution
spectrograph, the ASSURx analyzer has high resolving power in
the important Raman molecular ‘fingerprint’ region, allowing for
high material specificity and broad chemical coverage. Having the
sensitivity and resolution where it is needed in the Raman spectrum,
ensures the best material verification accuracy.
++Direct, non-invasive, non-destructive analysis through transparent/
translucent packaging
For both solids and liquids in sealed transparent or translucent pack-
aging, the ASSURx Handheld Raman Analyzer is the ideal material
verification tool. It can analyze through glass and polymer bags with
ease, whereas handheld NIR can be sensitive to some polymer packag-
ing differences, and struggles with liquids in-situ.
++ Direct connection data transfer between unit and PC/network
for easy data archiving
++ Meets regulatory compliance and requirements for: cGMP, 21 CFR
Part 11, USP 1120, EP 2.2.48
All data collected on the ASSURx analyzer is encrypted, secure and
audit trail tracked. Data on the ASSURx analyzer is read-only, and is
permanently stored on a large 240GB hard drive. Data can be download-
ed to PC or network storage location via a direct Ethernet connection or
secure USB Flash Drive to archive reports and raw data.
The ASSURx analyzer meets the Raman instrumentation require-
ments stipulated in USP 1120 and EP 2.2.48. Being methodically cali-
brated at the factory, and functionally checked before shipment and
at installation; TSI and TSI partners ensure ASSURx instruments are
fully compliant with pharmaceutical manufacturers’ regulatory needs.
++ Swappable, rechargeable batteries for continuous operation
++Rugged design with shoulder strap
Designed for all-day, continuous use, the ASSURx analyzer comes
with two batteries and a charging station so that while one battery is
in use, the second battery can always be charging. Since the charging
time of the battery is less than the use time of the battery, continuous
operation of the ASSURx analyzer is possible. For operators using
the ASSURx analyzer continuously, a comfortable shoulder strap is
provided that allows the instrument to be easily carried around.
Specifications
Laser Wavelength 785 nm

Laser Output Power 300 mW or below, adjustable on user-interface

Spectral Range 250-2350 cm-1

Spectral Resolution ~6 cm-1 (FWHM) across range
Detector Type TEC temperature-controlled linear CCD array
ASSURx-ID user-interface software for material verification, identification and library generation/management.
Software ASSURx Reporter PC-software for report viewing, and file conversion to .spc and .txt file formats
Discovery Library of ~200 chemicals.
Data Formats .SPC, .TXT, .EPT (encrypted)
Report Formats PDF with e-signatures
Connectivity USB, Ethernet
Barcode Reader Integrated. Compatible with most 1D linear barcodes
Operating Temperature 0-40 °C
Display Color touch screen; can be operated with gloves or integrated stylus
Battery Swappable, rechargeable Li-ion, >3 hours operation, <2 hours charge (Continuous operation possible)
AC Adapter DC Wall Adapter, 100/220VAC 50/60Hz
US FDA 1040, 21 CFR Part 11 software – includes audit trails, administrator controls for logins, secure
passwords with expirations, data encryption and integrity checks.
Compliance
USP Ch. 1120
EP Ch. 2.2.48
Dimensions (LxWxH) 9.21” x 4” x 8.77”
Weight 5.25 lbs.

Battery-charging stand, Spare battery, Vial Holder, Tablet Holder, 7 mm sampling lens, Ethernet Cable,
Accessories - Included
Polystyrene PQ check standard, Acetaminophen, Acetyl Salicylic Acid check samples.

Accessories - Optional Immersion probe

Warranty One Year for Parts and Labor. Extended warranties are available.
Installation Service & Support IQ/OQ/PQ documentation User Training included

FOR AN ON-SITE DEMONSTRATION, CONTACT A TSI® | CHEMLOGIX™ REPRESENTATIVE

BY VISITING TSI.COM/ASSURX OR CALL 800-874-2811.

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